Insulin detemir - Biologic Drug Details

Summary for insulin detemir

Tradenames:	1
High Confidence Patents:	14
Applicants:	1
BLAs:	1
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for insulin detemir
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for insulin detemir

Recent Clinical Trials for insulin detemir

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of California, Los Angeles	Phase 2
First Affiliated Hospital Xi'an Jiaotong University	N/A
Minneapolis Medical Research Foundation	N/A

See all insulin detemir clinical trials

Recent Litigation for insulin detemir

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31

See all insulin detemir litigation

Pharmacology for insulin detemir

Ingredient-type	Insulin
Established Pharmacologic Class	Insulin Analog

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for insulin detemir Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin detemir Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2026-07-17	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2037-11-17	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2037-02-24	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2039-01-17	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536			Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2008-02-10	Company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2014-04-08	Company disclosures

3) Low Certainty: US Patents for insulin detemir Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2033-03-11	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2032-04-18	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2031-06-02	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2035-07-15	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2035-07-15	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2029-01-28	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536		2034-10-24	Patent claims search

International Patents for insulin detemir

Country	Patent Number	Estimated Expiration
China	100571805
Canada	2258097
Australia	682061
China	1277558
Japan	4490496
Argentina	241801
Brazil	PI0606607

Supplementary Protection Certificates for insulin detemir

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2004005,C0792290	Lithuania		PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
132004901247576	Italy		PRODUCT NAME: INSULINA DETEMIR(LEVEMIR); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/04/278/001; 002; 003; 004; 005; 006; 007; 008; 009;, 20040601
SPC/GB04/036	United Kingdom		PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
SZ 28/2004	Austria		PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON
99C0044	Belgium		PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
2004C/020	Belgium		PRODUCT NAME: INSULIN DETEMIR; AUTHORISATION NUMBER AND DATE: 56370 01 20040601
122004000035	Germany		PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601 FIRST REGISTRATION: LIECHTENSTEIN 5637001 5637101 5637201 20031110